510(k) K191997
K191997 is an FDA 510(k) premarket notification submitted by Faico Medical, LLC for the device "FAICO CMF System". The FDA issued a decision of Substantially Equivalent on Apr 22, 2020. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Faico Medical, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 22, 2020
- Date Received
- Jul 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type
- 510(k)